SPARC™ is the brand name (trademarked by American Medical Systems, or AMS) of a bladder sling — a medical device that is inserted in a patient to support or reinforce internal tissues that have weakened or stretched, causing stress urinary incontinence (SUI) and/or pelvic organ prolapse (POP). SUI is estimated to affect one out of every three women over the age of 45, and POP is estimated to affect one out of every two women over 45.
SPARC™ Is a Bladder Sling
Medical treatments for stress urinary incontinence and pelvic organ prolapse (also called vaginal prolapse) range from non-invasive measures such as biofeedback and medications to extensive surgery. Bladder slings such as the SPARC™ Sling are implanted in a surgical procedure, to hold up the muscles that surround the urethra; the slings are often made of a product called "vaginal mesh."
FDA Investigation of Vaginal Mesh Products
Vaginal mesh has been the focus of several U.S. Food and Drug Administration (FDA) investigations. According to the FDA, it has received thousands of reports of injuries and severe adverse symptoms in women who'd had a bladder sling or other vaginal mesh implant.
A commonly reported injury linked to vaginal mesh is the "erosion" of the mesh, in which the vaginal mesh splits the internal tissues where it was implanted, letting the mesh protrude from the tissue. This can cause very serious bleeding, infections, chronic pain, and the recurrence of the pelvic organ prolapse and/or stress urinary incontinence.
American Medical Systems (which was acquired by Endo Pharmaceuticals in 2011) notes that the SPARC™ sling is "a minimally invasive system that utilizes a suprapubic approach to treat female urinary stress incontinence due to urethral hypermobility and/or intrinsic sphincter deficiency (ISD)." These two conditions are the main causes of stress urinary incontinence.
Learn More about the SPARC™ Sling
Women who are experiencing adverse symptoms of a bladder sling such as the SPARC™ — and women who are afraid of what might happen now that they've had a vaginal mesh product implanted — should learn about their legal options. To learn more, contact our vaginal mesh lawyers today. They are available to investigate potential claims on behalf of women who are injured by vaginal mesh products.